| CTRI Number |
CTRI/2024/06/068793 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
02/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trail on kalladaippu kudineer in the management of kalladaippu noi(urolithiasis) |
|
Scientific Title of Study
|
A Prospective, open labelled, non randomized, phase II clinical trial on Kalladaippu kudineer in the management of Kalladaippu Noi( Urolithiasis) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PANDEESWARAN J |
| Designation |
PG scholar |
| Affiliation |
Government Siddha Medical College, Palayamkottai |
| Address |
Op number 10, PG department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Tiruvananthapuram main road, Palayamkottai Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9597652976 |
| Fax |
|
| Email |
pandijeganathan1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr T KOMALAVALLI ALIAS MEHALA |
| Designation |
Head of Department |
| Affiliation |
Government Siddha Medical College and Hospital palayamkottai |
| Address |
Op number 10,PG department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Thiruvananthapuram road,Palayamkottai,Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9788122691 |
| Fax |
|
| Email |
Komalaarumugam1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr T KOMALAVALLI ALIAS MEHALA |
| Designation |
Head of Department |
| Affiliation |
Government Siddha Medical College and Hospital palayamkottai |
| Address |
Op number 10,PG department of Pothu Maruthuvam Government Siddha Medical College and Hospital, Thiruvananthapuram road,Palayamkottai, Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9788122691 |
| Fax |
|
| Email |
Komalaarumugam1@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD facilities and central library of government siddha medical college and hospital, Tiruvananthapuram main road, Palayamkottai,Tirunelveli-627002,Tamilnadu, India |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College and Hospital |
| Address |
PG department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Thiruvananthapuram main road, Palayamkottai,Tirunelveli-627002,Tamilnadu, India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| J Pandeeswaran |
Government Siddha Medical College and Hospital |
Op number 10,PG department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Tiruvananthapuram main road, Palayamkottai-627002,India
Tirunelveli
TAMIL NADU |
9597652976
pandijeganathan1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee,Government Siddha Medical College and Hospital, Palayamkottai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N20-N23||Urolithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kalladaippu kudineer |
DOSAGE:30-60ml twice a day Orally for 45 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Evidence of renal calculus,confirmed by using
2.Renal colicky pain
3.Haematuria
4.Oliguria
5.Dysuria
6.Nausea,vomiting |
|
| ExclusionCriteria |
| Details |
1.Chronic appendicitis
2.Pyelonephritis
3.Recurrent UTI
4.Chronic renal failure
5.Bilateral obstructive uropathy
6.Diabetes mellitus
7.Metabolic disorder like hyperthyroidism, hyperparathyroidism |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome will be aimed at reducing clinical symptoms and calculi size ,will be considered as successful outcome of the treatment |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To collect various siddha and modern journals for literature review on KALLADAIPPU NOI
2.To evaluate the clinical lithotriptic and diuretic pharmacological activities of trail drug
3.To evaluate additional effects and siddha parameters, Envagai thervugal changes in KALLADAIPPU NOI
4.To evaluate the safety profile for acute and sub-acute toxicity of the trail drug
5.To perform biochemical analysis
6.To perform usg abdomen in selected cases
|
6months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is A Prospective, openlabelled, non randomized, phase II clinical trial on Kalladaippu kudineer in the management of Kalladaippu noi (Urolithiasis).After authentication and purification of the Kalladaippu kudineer is prepared and administered at the dosage of 30-60ml (Twice a day orally) for 45 days known renal calculi Patients (40 (IP & OP )patients). The primary outcome will be determining the effectiveness of Kalladaippu kudineer in the management of Kalladaippu noi.The secondary outcome will be to collect various siddha literatures and modern science journals,to evaluate the clinical lithotriptic & diuretic pharmacological activities of trial drug,to Evaluate additional effects & Siddha parameters, Envagai thervugal changes inKalladaippu noi (Urolithiasis),to evaluate the safety profile for acute & sub acute toxicity of the trial drug, to Perform Biochemical analysis and to Perform Usg Abdomen in selected cases. |